In-depth understanding of QbD, Quality Risk Management and lifecycle management principles, and relevant regulatory framework, such as ICH Q8, Q9, Q10, Q11, Q12. * Understanding of the principles of risk-based small-molecule process control strategy development, specification management (ICH Q6) and impurity management (ICH Q3 group of guidelines, ICH M7, latest regulatory standpoint on nitrosamines). * Maintain daily contact with the of non-chromatographic release and IPC labs to ensure optimal support for testing laboratories. * Drive complex scientific / quality investigations in your field in a cross-functional team and facilitate related remediation plans (e.g., CAPA plan). * Liaise with relevant organizations, such as QA, chemical production, R&D, CMC RA and build a network of contacts to support troubleshooting. * Drive systematic changes in QC non-chromatographic area, create and assess change ...
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